SENSILASE PAD 3000

K040654 · Optical Sensors, Inc. · DPW · Jun 4, 2004 · Cardiovascular

Device Facts

• Record ID: K040654
• Device Name: SENSILASE PAD 3000
• Applicant: Optical Sensors, Inc.
• Product Code: DPW · Cardiovascular
• Decision Date: Jun 4, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Indications for Use

The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

Device Story

SensiLase PAD 3000 measures skin perfusion pressure (SPP) and pulse volume recording (PVR) on patient extremities. Device uses pressure cuff to occlude blood flow; laser sensor assembly (LSA) detects skin perfusion. Cuff inflates until perfusion is near zero; pressure releases until perfusion increases; cuff pressure at that point defines SPP. PVR measures pulsatile pressure amplitude via partially inflated cuff. Output is waveform printout interpreted by vascular specialist. Used in clinical settings to evaluate peripheral microcirculation and arterial blockage. Benefits include noninvasive assessment of perfusion.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological and functional comparison to the predicate device.

Technological Characteristics

System includes pressure cuff and laser sensor assembly (LSA). Laser diode specifications: 785 nm wavelength; 2.3 mW typical power (3.0 mW max). Laser classification: Class I per 21CFR1040.10; Class 1M per IEC 60825-1. Device provides SPP and PVR measurements.

Indications for Use

Indicated for noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on patient extremities to assess perfusion and arterial blockage.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Predicate Devices

• Model PV2000 Vascular Microlaboratory (K951486)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date JUN - 4 2004 on the left side. On the right side, there is the text "OPTICAL SENSORS INCORPORATED" and the number K040654. There is a black diamond shape in the middle of the image with lines coming out of it.

# Summary of Safety and Effectiveness

| Company Name: | Optical Sensors Incorporated.<br>7615 Golden Triangle Drive<br>Eden Prairie, MN 55344 | |
|----------------------------|---------------------------------------------------------------------------------------|--|
| Contact:<br>Phone:<br>Fax: | Paulita LaPlante, President and CEO<br>[phone]<br>[phone] | |
| Summary Date: | March 11, 2004 | |
| Trade Name: | SensiLase™ PAD 3000 Skin Perfusion Pressure System | |
| Common Name: | Blood Flowmeter | |
| Classification Name: | 21 CFR 870.2100, Flowmeter, Blood; Class II,<br>Product Code: DPW; Product Code: | |
| Predicate Device: | | |
| | 510(k) Number: K951486 | |
| | Manufacture: Vasamedics, LLC | |
| | Trade Name: Model PV2000 Vascular Microlaboratory | |

## 1.0 Description of Device

The SensiLase™ PAD 3000 (SensiLase™) Skin Perfusion Pressure System provides measurements of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR). Both measurements may be clinically applied to assess perfusion. Both the SPP and PVR measurements are features of the predicate PV2000 device. The same methods arc applied for measurement of SPP and PVR as the predicate PV2000.

The SPP measurement is performed by applying a pressure cuff capable of occluding skin blood flow (perfusion). The pressure cuff is inflated until the skin perfusion, as detected by a Laser Scnsor Assembly (LSA) underneath the cuff, is determined to be near zero or significantly reduced. The pressure is released until an increase in skin perfusion is determined. The cuff pressure when the skin perfusion increases is the SPP value. SPP is a test used to evaluate peripheral microcirculation.

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The measurement of the pulse volume recording (PVR) waveform is a measure of the pulsatile pressure amplitude resulting from a partially inflated cuff encircling the limb. The PVR is used as a more direct measurement of arterial blockage. The test output is a printout of the waveform, which is interpreted by a vascular specialist.

The clinical application and interpretation of the Perfusion , SPP measurements and interpretation of the PVR Waveform is the same as the predicate PV2000.

#### Intended Use 2.0

The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

#### Technology 3.0

The SensiLase instrument contains a laser diode that is used when performing the skin perfusion pressure measurement. Laser specifications are:

- Power exiting LSA: 2.3 milliwatts (typical), 3.0 milliwatts maximum. l.
- 2. Wavelength: 785 nm
- Laser Classification per 21CFR1040.10 : Class I 3.
- Laser Classification per IEC 60825-1: Class 1M 4.

The same technology was applied in the predicate PV2000 device.

## Conclusions 4.0

The intended use, technology, features and performance of the SensiLase™ PAD 3000 Skin Perfusion Pressure System are substantially equivalent to the predicate PV2000. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN - 4 2004

Optical Sensors Incorporated c/o Mr. Gary Syring Principal Consultant Quality & Regulatory, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K040654

SensiLase™ PAD 3000 Regulation Number: 21 CFR 870.2100 Regulation Name: Flowmeter, Blood, Cardiovascular Regulatory Class: Class II (two) Product Code: DPW Dated: March 11, 2004 Received: March 12, 2004

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Gary Syring

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that 1 271 0 resumes or over device complies with other requirements of the Act that I DA has made a doted regulations administered by other Federal agencies. You must or any I catal statutes and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 0077; mooning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in the letter will allow you to begin marketing your device as described in your Section 510(k) Fins letter will and w you'ls ough finding of substantial equivalence of your device to a legally premance moticated wice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you t the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to (2001) 37 + 1055 - 1055 - 105.97) you may obtain. Other general information on your premaintentifically.com (e obtained from the Division of Small Manufacturers, Itsponsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

NAerain May

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _SensiLase™ PAD 3000_____________________________________________________________________________________________________________________________________________

Indications For Use:

The SensiLase™ PAD 3000 provides a noninvasive measurement of Skin Perfusion Pressure (SPP) and Pulse Volume Recording (PVR) waveforms on extremities of patients.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C Mesar Miff

ardiovascular Devices Division of

KO40654 510(k) Number_

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